FDA 510(k)

Kubec Xpert 80 放射學系統

K 號：K210957 · 2021-08-31

決定日期2021-08-31

產品代碼MWP

諮詢委員會RA

決定相當於

器材摘要

Kubec Xpert 80 Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210957. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kubec Xpert 80 Radiography System?

Kubec Xpert 80 Radiography System is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210957.

When did Kubec Xpert 80 Radiography System receive FDA 510(k) clearance?

Kubec Xpert 80 Radiography System received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210957.

Who is the listed applicant for Kubec Xpert 80 Radiography System?

The FDA 510(k) record lists Kub Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kubec Xpert 80 Radiography System?

The FDA product code for Kubec Xpert 80 Radiography System is MWP.

其他以 Kub Technologies, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K210955Kubtec 莫扎特超級（XPERT 84）X光攝影系統 K210956Kubtec 莫扎特 (XPERT42)K200756Kubtec 莫扎特超級 K183624Kubtec 莫扎特 (Xpert42)

相關器械（代碼：MWP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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